Igraine Plc - ARCADIA trial completes and commercialisation plans

9 September 2021

THE INFORMATION CONTAINED WITHIN THIS ANNOUNCEMENT IS DEEMED BY THE COMPANY TO CONSTITUTE INSIDE INFORMATION AS STIPULATED UNDER THE MARKET ABUSE REGULATION (EU) NO. 596/2014, AS AMENDED ("MAR"). ON THE PUBLICATION OF THIS ANNOUNCEMENT  VIA A REGULATORY INFORMATION SERVICE ("RIS"), THIS INSIDE INFORMATION IS NOW CONSIDERED TO BE IN THE PUBLIC DOMAIN.

Igraine plc

AQSE: KING

(“Igraine” or "the Company")

Investee Update: Excalibur Medicines reports completion of ARCADIA trial & starts to progress commercialisation plans

Investee: EML

Igraine plc maintains a 2% Equity Interest in, Excalibur Medicines Ltd ("EML"), consistent with the terms of the co-investment agreement entered with Excalibur Healthcare Services, a company founded by renowned biotech entrepreneur and the company's Executive Chairman, Professor Sir Christopher Evans.

Excalibur Medicines Ltd (EML) is a subsidiary of Excalibur Healthcare Services, founded by leading scientific entrepreneur, Professor Sir Chris Evans, OBE. EML brought together the scientific intellectual property, international funding and a world leading team to take forward the ARCADIA trial. Professor Evans and the Excalibur team sourced investment from Mubadala of Abu Dhabi, one of the world’s leading sovereign wealth funds, Excalibur itself, several high net worth individuals, Igraine plc (AQSE: KING) & an HM Government grant through the UKRI/Innovate UK programme.

Excalibur Medicines Ltd ("EML") has secured exclusive rights to and owns the patents on a drug, AZD1656, which is being developed as a potential therapeutic for people with diabetes suffering from COVID-19. As there are very few new therapeutics in development for COVID-19 and associated virally transmitted diseases (most research is in combining existing treatments) this has the potential to be highly attractive to big pharma and biotech buyers.

ARCADIA Results & Commercialisation Plans

 Results from ARCADIA Phase II Clinical Trial of A Potential Therapy for COVID-19

St George Street Capital, a UK-based biomedical charity, and Excalibur Medicines Ltd., a biotechnology investment company, are pleased to announce the receipt of the final data from the ARCADIA Phase ll clinical trial which was conducted to assess a therapy that could treat diabetic patients suffering from COVID-19.

In light of the encouraging trial results, St George Street Capital and Excalibur will immediately start to undertake commercial discussions with potential licensees and/or fundraise for further clinical trials to investigate AZD1656 in a larger study. Further analysis to determine the precise nature of the biological effects of AZD1656 that explain the observed clinical outcomes will also be conducted.

The trial data has shown the following:

Efficacy:

A strong trend towards reduced mortality in patients receiving AZD1656. This was noted in both mortality on treatment and all-cause mortality, which were lower in the AZD1656 group compared to the placebo group. The strong trend to improved mortality for patients on AZD1656 was observed on top of patients receiving other medication, including dexamethasone, as part of standard of care. Certain clinically and biochemically defined subsets of patients appeared to benefit most from treatment with AZD1656. The data from ARCADIA supports continued investigation of AZD1656 for the treatment of patients with COVID-19, with or without diabetes, in future clinical trials.

Safety and Tolerability:

AZD1656 was shown to be well-tolerated in this patient population with no serious adverse reactions (SARs) occurring. The degree of glycaemic control, as measured by the need to increase baseline medication requirements or the need to add additional diabetic medications, was no different between the AZD1656 group and the placebo group. The proportion of Serious Adverse Events (SAEs) was numerically lower in the AZD1656 group compared with the placebo group. The proportion of Treatment Emergent Adverse Events (TEAE) was also no different between the groups. Overall no safety concerns were identified regarding the use of AZD1656 in this patient population.

Diabetes, whether type 1 or 2, has been the leading single cause of co-morbidity during the pandemic and one in three of all deaths with COVID-19 in hospital in England have been associated with diabetes.

About the ARCADIA Trial

AZD1656 was identified by St George Street Capital as a potential treatment for people with diabetes infected with COVID-19.

The objectives of the ARCADIA clinical trial were to assess the safety and tolerability of a glucose kinase activator, AZD1656, and to determine the effect of the therapy on clinical improvement and mortality in people with diabetes hospitalised with COVID-19. The trial also explored whether AZD1656 benefits COVID-19 patients via its effects on immune function.

ARCADIA was a randomised, double-blind, placebo-controlled Phase II clinical trial involving 153 patients. The clinical trial was arranged and structured by Professor Sir Chris Evans, Chairman and CEO of Excalibur Healthcare Services, through its subsidiary, Excalibur Medicines Ltd. Sir Chris worked closely with Professor John Martin and his team at St George Street, a UK-based biomedical research charity, which secured the initial project and permission to run the trial from AstraZeneca.

The full announcement can be viewed here:www.excaliburhealth.co.uk/news or www.sgscapital.org

Martin Walton, Executive Director, said: “The data from the trial is very encouraging and the company looks forward to the next developments in this exciting project. The trial results are promising and AZD1656 has the potential to be an important treatment for people with diabetes who have COVID-19.”

The Directors of the Company, who have issued this RIS announcement after due and careful enquiry, accept responsibility for its content.

Enquiries

Company:

Martin Walton (Executive Director)

Steve Winfield (Executive Director)

info@igraineplc.com

Office Line: +44 (0) 20 3778 0755

AQSE Growth Market Corporate Adviser

Peterhouse Capital Limited

Guy Miller / Allie Feuerlein

Tel: +44 (0) 207 469 0930

Media inquiries:

Ramsay Smith, Media House International

ramsay@mediahouse.co.uk: +44 (0) 7788414856